Darvadstrocel

Summary

Darvadstrocel (CHEMBL4298180) is an approved cell (ATC L04AX08); indicated across 3 conditions including immune system disorder and anal fistula.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Cell
• ATC class: L04AX08
• Indications: 3 conditions
• Clinical trials: 11

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4298180
Name	Darvadstrocel
Type	Cell
Max phase	4
ATC	L04AX08

Also known as: Alofisel, CX-601, Cx601, Darvadstrocel, DARVADSTROCEL

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

2 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
immune system disorder	4	MONDO:0005046	EFO:0000540
anal fistula	4	MONDO:0000754

1 disease in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
Crohn disease	3	MONDO:0005011	EFO:0000384

Clinical trials

Total trials: 11.

Phase distribution

Phase	Trials
PHASE3	5
Not specified	4
PHASE4	1
PHASE1/PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04118088	PHASE4	TERMINATED	A Study of Darvadstrocel in Adults With Crohn’s Disease and Complex Perianal Fistula
NCT01541579	PHASE3	COMPLETED	Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn’s Disease
NCT03279081	PHASE3	COMPLETED	Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn’s Disease (CD)
NCT03706456	PHASE3	COMPLETED	Phase 3 Study of Cx601 in Participants With Complex Perianal Fistulising Crohn’s Disease
NCT04075825	PHASE3	COMPLETED	Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
NCT04701411	PHASE3	TERMINATED	A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn’s Disease
NCT01372969	PHASE1/PHASE2	COMPLETED	Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn’s Disease.
NCT05113095	Not specified	RECRUITING	A Survey of Darvadstrocel in People With Crohn’s Disease
NCT05974280	Not specified	RECRUITING	Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells
NCT05322057	Not specified	COMPLETED	Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn’s Disease
NCT05742100	Not specified	COMPLETED	Darvadstrocel for Crohn’s Fistula in the Realworld

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).